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Sponsored by: |
Instituto Valenciano de Infertilidad, Spain |
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Information provided by: | Instituto Valenciano de Infertilidad, Spain |
ClinicalTrials.gov Identifier: | NCT00633347 |
Oocyte donation is a well established procedure in assisted reproduction treatments (ART). It is demonstrated that the use of hormonal substitution therapy, for the synchronization of the cycles between the recipients and the donors, provides good results, similar to the ones obtained with the natural cycle. In the patients - recipients with preserved ovarian function, the recipient's natural cycle is annulled, thus preventing the spontaneous Luteinizing Hormone surge. Simultaneously and while waiting for the suitable donor, her endometrium is prepared. When the donation occurs and fertilization with the husband sperm takes place, her cycle is stimulated again in order to synchronize her window of implantation with the donor's ovulation.
Two different medications are commonly used to inhibit spontaneous ovulation: either GnRHa agonist or GnRH antagonists. The present study consists of the comparison between the single dose GnRH agonist (Decapeptyl 3,75 IM) and the 7 day dosage of GnRH antagonist (Cetrotide 0,25 mg). The administration of GnRHa is used fundamentally as a long liberation formulation, administered in a single intramuscular injection (IM), which is more practical in terms of use. Nevertheless, the unnecessary persistence and the potentially unfavorable action of GnRHa during the luteal phase and early gestation have questioned its use. The recovery of the Hypophysarian function begins only 8 weeks after the single injection of long liberation of triptorelina 3.75 mg. The GnRH antagonist (Cetrotide 0,25 mg) makes the hypofisary inhibition shorter than with the analogues and can prepare similar endometrium characteristics as a natural cycle. The recipients will be assigned randomly to a group of treatment or another.
Condition | Intervention | Phase |
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Infertility |
Drug: Antagonist GnRH Cetrotide Drug: Agonist GnRH Acetate Triptoreline |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 400 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
A: Antagonist
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Drug: Antagonist GnRH Cetrotide
Cetrotide 0.25 mg. daily/ 7 days
Drug: Agonist GnRH Acetate Triptoreline
Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose
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B: Active Comparator
Agonist GnRH
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Drug: Agonist GnRH Acetate Triptoreline
Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose
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Ages Eligible for Study: | 18 Years to 44 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carmina Vidal, MD PhD | 34963050900 | cvidal@ivi.es |
Spain | |
IVI Valencia | Recruiting |
Valencia, Spain, 46015 | |
IVI Valencia | Recruiting |
Valencia, Spain, 46015 | |
Contact: Leslie atkinson, BS, Ms latkinson@ivi.es | |
Principal Investigator: Carmina Vidal, MD PhD |
Responsible Party: | IVI Valencia ( IVI Valencia ) |
Study ID Numbers: | VLC-CV-1006-02 |
Study First Received: | February 21, 2008 |
Last Updated: | March 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00633347 History of Changes |
Health Authority: | Spain: Ministry of Health |
oocyte donation endometrial preparation |
Genital Diseases, Female Infertility Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
Cetrorelix Genital Diseases, Male Hormones |
Genital Diseases, Female Infertility Hormone Antagonists Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Cetrorelix Genital Diseases, Male Pharmacologic Actions |